Positive Top-Line Results for Bimekizumab in Phase 3 Ankylosing Spondylitis Trial

BRUSSELS and ATLANTA, Dec. 16, 2021 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced positive top-line interim analysis results from the Phase 3 BE MOBILE 2 study, which is evaluating the efficacy and safety of bimekizumab in adults with active ankylosing spondylitis.¹ BE MOBILE 2 is one of two Phase 3 studies evaluating bimekizumab across the full spectrum of axial spondyloarthritis (axSpA) disease, which includes both ankylosing spondylitis and non-radiographic (nr)-axSpA.^1,2,3

The BE MOBILE 2 study met its primary endpoint, as measured by the proportion of patients who achieved the Assessment of SpondyloArthritis International Society 40 (ASAS40) response at week 16, when compared to placebo.¹ ASAS40 measures improvements in disease across different domains, including patient global assessment of disease activity, spinal pain, physical function and inflammation.² The primary endpoint used in this study, ASAS40, set a high threshold for improvement in patient-reported outcomes, i.e., at least a 40 percent improvement relative to baseline.*

The study also met all ranked secondary endpoints, including significant improvements with bimekizumab over placebo at week 16 in patient-reported disease activity, as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); achievement of ASAS partial-remission (PR) and Ankylosing Spondylitis Disease Activity Score (ASDAS) Major Improvement (MI); and the nocturnal spinal pain score.¹ 

"Ankylosing spondylitis is a painful, chronic, inflammatory rheumatic disease that often starts in young adulthood. The encouraging top-line Phase 3 results reported today are consistent with the Phase 2 findings and suggest that bimekizumab has the potential to deliver clinically meaningful improvements in the key signs and symptoms of the disease," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. "Today's findings for bimekizumab in ankylosing spondylitis follow closely behind the positive results in psoriatic arthritis reported last month and reinforce our continued commitment to advancing standards of care."

In BE MOBILE 2, the safety profile of bimekizumab was consistent with safety findings seen in previous studies with no new observed safety signals.¹ The safety and efficacy of bimekizumab in ankylosing spondylitis have not been established, and it is not approved for use in ankylosing spondylitis by any regulatory authority worldwide.¹

Results from the BE MOBILE 2 study will be presented at upcoming medical conferences and published in a peer-reviewed medical journal. BE MOBILE 2 is one of two parallel Phase 3 studies evaluating bimekizumab in the treatment of patients across the axSpA disease spectrum.^1,2 The second study, BE MOBILE 1, is evaluating the efficacy and safety of bimekizumab in the treatment of patients with active nr-axSpA³ and is expected to report top-line results soon. 

*ASAS40 is achieved when there is at least a 40 percent improvement relative to baseline, and an absolute improvement of at least two units on a 0-10 numeric rating scale in at least three of the four domains that make up the ASAS response criteria—patient global assessment of disease activity, spinal pain, physical function and inflammation—with no worsening in the remaining domain.² 

About BE MOBILE 2
BE MOBILE 2 is a randomized, multicenter, double-blind, placebo-controlled, parallel group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active ankylosing spondylitis.² BE MOBILE is the first Phase 3 bimekizumab research program to include patients from China in its study population. BE MOBILE 2 enrolled 332 participants with moderate to severe active disease. ² Study participants had to have no response to two different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of four weeks, or have had a history of intolerance to or a contraindication to NSAID therapy.² Patients who had taken a tumor necrosis factor alpha (TNFα) inhibitor had to have experienced an inadequate response or intolerance to treatment.² The 52-week study is ongoing with top-line interim analysis results presented above. For additional details on the study, visit BE MOBILE 2 on clinicaltrials.gov.

About Axial Spondyloarthritis
Ankylosing spondylitis falls under the umbrella of axial spondyloarthritis (axSpA), which also includes non-radiographic (nr)-axSpA.⁴ axSpA is a painful chronic inflammatory disease that primarily affects the spine and the joints linking the pelvis and lower spine (sacroiliac joints).⁵ The leading symptom of axSpA is inflammatory back pain that improves with exercise, but not with rest.⁴ Fatigue and stiffness are additional key symptoms. Other common clinical features frequently include acute anterior uveitis (eye inflammation), enthesitis (inflammation of the points of insertion of tendons and ligaments into bone), peripheral arthritis, psoriasis, inflammatory bowel disease (chronic inflammation of the digestive tract) and dactylitis (inflammation of the fingers or toes).⁴ The overall prevalence of axSpA is 0.2 percent to 1.4 percent of adults, similar to rheumatoid arthritis.^6,7,8 Approximately two-thirds of patients with ankylosing spondylitis are men,⁹ while nr-axSpA is more common among women with the disease.⁹ axSpA onset usually occurs before the age of 45, often in the 20s.⁴ 10 to 40 percent of patients with nr-axSpA progress to ankylosing spondylitis over 2 to 10 years.⁴ 

About bimekizumab
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively and directly inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.¹⁰

Bimekizumab is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe plaque psoriasis in adults, and its efficacy and safety have not been established for any indication in the U.S.

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7 600 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @ucbusa.

Forward looking statements UCB
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UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

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For further information, contact UCB:

References

¹ Data on file. UCB. December 2021.
² ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis (BE MOBILE 2). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03928743. Last accessed: December 2021.
³ ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis (BE MOBILE 1). Available at: https://clinicaltrials.gov/ct2/show/NCT03928704. Last accessed: December 2021.
⁴ Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed Care. Am J Manag Care. 2019;25:S319-S330.
⁵ van der Heijde D, Gensler L, Deodhar A, et al. Dual Neutralisation of interleukin-17A and interleukin-17F With Bimekizumab in Patients With Active Ankylosing Spondylitis: Results From a 48-week Phase IIb, Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging Study. Ann Rheum Dis. 2020;79(5):595-604.
⁶ Reveille J, Witter J, Weisman M. Prevalence of axial spondylarthritis in the United States: estimates from a cross-sectional survey. Arthritis Care Res. 2012;64(6):905-910.
⁷ Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondyloarthritis in the UK: a cross-sectional cohort study. BMC Musculoskelet Disord. 2015;21(16):392.
⁸ Spector T. Rheumatoid arthritis. Rheum Dis Clin North Am. 1990:16(3):513-537.
⁹ Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.
¹⁰ Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991-1001.

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